New Med Approved for Opioid-Induced Constipation

[icnmgrjill]

FDA Approves Relistor for Opioid-Induced Constipation
Drug will help reduce effects of drugs like morphine on bowel function

The U.S. Food and Drug Administration today approved Relistor (methylnaltrexone bromide) to help restore bowel function in patients with late-stage, advanced illness who are receiving opioids on a continuous basis to help alleviate their pain.

Opioids are often prescribed on a continuous basis for patients with late-stage, advanced illness to help alleviate pain. This includes patients with a diagnosis of incurable cancer, end-stage Chronic Obstructive Pulmonary Disease (COPD) from emphysema, heart failure, Alzheimer’s disease with dementia, HIV/AIDS or other advanced illnesses.

Opioids can interfere with normal bowel elimination function by relaxing the intestinal smooth muscles and preventing them from contracting and pushing out waste products. Relistor acts by blocking opioid entrance into the cells thus allowing the bowels to continue to function normally.

“This new drug will be helpful to patients who experience severe constipation associated with the continuous use of morphine or other opioids, which are an important part of care for patients with late-stage, advanced illness.” said Joyce Korvick, M.D., deputy director of the Division of Gastroenterology Products, FDA.

Relistor is an injectable medication. It can be administered as needed, but not to exceed one dose in a 24 hour period. The recommended starting schedule is one dose every other day as needed for patients with late-stage advanced illness. Relistor is not recommended for patients with known or suspected intestinal obstructions.

Common side effects include abdominal pain, gas, nausea, dizziness and diarrhea. If severe diarrhea, vomiting, nausea or abdominal pain occurs while taking Relistor, patients should discontinue use of the medication in consultation with their health care professional.

The safety and effectiveness of the drug was demonstrated in clinical studies conducted by the sponsors. The two randomized, double-blind placebo-controlled studies involving a total of 287 participants were conducted over a four month period. The median age of the study participants was 68 years, and 51 percent of the participants were women. In both studies, all patients had advanced late-stage illnesses with a life expectancy of less than 6 months. Prior to treatment with Relistor, participants had either less than three bowel movements in the week prior to treatment or no bowel movement for more than 2 days. Patients who were treated with Relistor had a significantly higher rate of elimination than those receiving placebo. The safety and effectiveness of Relistor have not been studied in pediatric populations.

Relistor is manufactured by Wyeth Pharmaceuticals Inc., Philadelphia, PA., and Progenics Pharmaceuticals, Tarrytown, NY.

[mlzippy7]

Has anyone tried this med yet? My dr just prescribed it today. You have to give yourself shots just like a diabetic kind of.
I am wondering if anyone is using it. I still am using the Miralax 4 times a day as well.
Thanks for any info!!

[Kara29]

Jill,

This could be a HUGE life saver for me because I've spent my WHOLE summer in the Hospital with this issue. I'll ask my Doc about it at my oepration next week. THANK YOU!!!!!!!!!!!!!!!!!!!!!!!!

Kara

[Eloise]

That Relistor sounds like a great break through. Thanks Jill.

Mizippy7 - How long have you been on MiraLax four times a day? I didn't know you could take it that many times - I'm glad to hear this. I was on it but just once a day and after a number of years it quit working. I've had a history of constipation since high school and I'm in my 60's now. I've tried everything there is. Now my GI has me on mineral oil. Did your doctor tell you to take it four times a day? I'd rather take MiraLax four times a day than the mineral oil. I'm thinking I'm going to have to talk to my GI about this.

Eloise

[mlzippy7]

I have had constipation issues since I was a baby! Many many years!!
I have seen so many GI drs and YES they told me to take the miralax that many times a day. I would NEVER just take it without my drs telling me to.
I have been on miralax 4 or so years already and taking it 4 times a day for over 2 years. I still only go once or twice a week if I am lucky and have lots of bleeding fissures to deal with.
If you want to chat more about this feel free to email....I know too much information to share!!!!!!!!!

[Eloise]

Thank you, Mizippy7, for replying to my post. I am going to definately talk to my GI about the MiraLax.

Eloise

[Kara29]

Jill or anyone else that can help answer my question. Is it an injection that you can administer to yourself subcuteanously (like fertility injections)? or do you have to go to your Doctors office and have them do it?

Thanks for any more info that can be found regarding administration. Is this drug on the market yet?

Thank You Again,

Kara

[mlzippy7]

Kara
It is an injection you give yourself at home subcuteanously.
If you need more infor I am happy to help!

[Kara29]

None of my Doctors will give it to me because they have never heard of it. I've called 3 so far. At this point I'm crying because I've already done two Enema's with minimal results. Its so helpless when no one hears you cry.

I already know that I'm going to end of in the ER and they will do the same test on me over again, cat scans, x-rays, then they say you are fine just constipated. Then they send me home.

The tears are coming out so fast I can barely see the keyboard. If a med works why is it so hard to give it a try?

I don't want to go to the Hospital again.............I've been going in every other week.

I take Hydrocodone 10/325 twice a day but can take it up to 4 times a day but I don't for fear of even worse constipation. We've tried every over the counter med and prescription med except for this one.

I hate it how these Doctors are going home to a nice family life while I'm going to spend my night in the ER fighting for pain relief from backed up bowels.

Mlzippy (do you take it?)

I looked it up and this is not the same ingredients that are in Miralax and Lactolose as well as the rest of them. This one seems to be in a category all alone, is that correct?

I'm so upset. And in so much pain. I was excited to see this post from Jill because I thought, WOW maybe this could actually be the one that works and my Hospital Visits will end soon.

Kara

[leelee88]

Kara,

Do NOT give UP. If you have to go to the ER Please print this article out that Jill has posted!! Take it with you!! Tell them that none of your Drs no about this and ask them IF they KNOW any DR that do.. My heart is breaking for you..I would also fax any information I could find about this drug to ALL your Drs!! Maybe Mary> Mlzippy7 could email you the info about it?

[mlzippy7]

Kara I sent you a pm.

[Kara29]

Doctor number 4 said no. He said they only give it to paitents who are in Hospice and are Dying. I guess I will have to go back to the ER. He told me to do an emena every day instead of every other day. I told him I had a hole burning through my flesh in my anus. Due to emema usage every other day. He said he could not help me and to call me Primary. Did that and nothing....................

I am at a loss. I really thought this could help.

I'm very upset.

I cant think when I am in this much pain and don't know what to do. The ER's just treat me with a cat scan and then they send me home.................

I don't know how to get through to the next couple of days until I see my pelvic pain specialsit and he won't help me either with this issue. I have a GI Specialist Appointment on September 15th but I can't make it that far unless I stop eating entirely......................................

I'm supposed to be the Strong One Here but I have nothing to offer myself to help. I keep thinking about what I should do for enough relief to get to Monday.


I thought Doctors were supposed to help in crisis situations. I can't even begin to count the number of Doctors I saw for IC. I really don't want to go through this again. My OBGYN said that a GI Doc would not be able to help me, however he won't help me either.

I am throwing my hands up. I keep going back and forth in my head. ER, NO ER, ER, NO ER, ER, NO ER...................You have to wait like 18 hours to get there and then after they give me the gastrograh for the cat scan.....I have severe diarhea and then the whole cycle starts all over again.

I'm trying so hard to be the Strong Kara that I usually am but this has taken away my whole summer, bouncing back and forth between one specialist to another and none of them will touch me.

I'm sorry.

Kara

Kara

[SandyRN]

Kara, my heart just aches for you. I'm so sorry you are going through so much pain without any help. What ARE you taking by mouth for constipation? I know when I am THAT constipated an enema does absolutely NOTHING. I don't even buy them anymore. I did find some help with dulcolax suppositories. You have to insert them WAY up there, as far as you can, and let them sit for an hour or so. The longer you hold them the better they work. They still aren't an answer but they give me some relief, and sometimes they carry over to the next day if I've held it long enough and then I'll have 2 bm's in2 days which is a miracle for me. I do take Miralax but can't get the dosage right...I either take too much with gives me severe diarrhea or I don't take enough and bloat in pain.

Your post just touched my heart. You have been through so much sweetie and you don't deserve anymore pain and heartache. I can't believe nobody will help you. Obviously this med isn't just for hospice patients or mlzippy wouldn't have it!! What is WRONG with these doctors?

It's times like these that I get so frustrated with the entire medical system. These doctors DO go home to a comfy, rich, satisfied life while they leave their patients untended to and in pain.

The only thing I can offer is what was already said. Take this with you to the ER, ask them for an RX....make them pull your file, you have to have a big one just for the constipation visits....see if they will write it for you even if just for a trial run....anything but sending you home empty handed again.

I'm thinking and praying for you and hope that you get all you want and need out of life. You have been an inspiration to me, I want you to know that. I am so afraid of the upcoming surgery I am going to have for a total abdominal hysterectomy. I am scared mostly because of pain control, and I stop and think of you and all you have been through and how you have handled it so strongly. It gives me hope that I will come through my surgery as strong as you have gone through yours.

Please carry this with you in your heart and know that you have touched mine, in more ways than one.

My best to you sweetie....let us know how things turn out.

Hugs, Sandy

[Kara29]

OMG SANDY!

Thank you for hearing my cry and understanding that I just can't hold it together all of the time. I am going to PM you. I LOVE YOU for your kind words and support! I've been feeling very lonely lately. No friends around to help, just family. You name it I've tried it by mouth inlcuding drinking Mineral Oil. I've done every single thing over the counter and prescribed. I've done every thing they have told me to. I have the dulcolax suppositories but they also burn and I'm bleeding from wiping so many times. I've used lidocane down there but it still burns.

I am going to PM You..............I don't know what I did in life to deserve the way I'm being treated, even by the one Doctor who said he'd DO ANYTHING for me and he said this last week?????? (My Primary)

Love and Hugs,

Kara

[SharonA]

Kara...I just do not know what to say. This is so unbelievable. I really do not understand. It's not like you are asking for something illegal.

I don't have any advice. I just hope you are able to get some help. And don't you worry about being strong for us. That's not necessary right now. You need to take care of yourself.

(((Hugs))) and lots of love being sent to you. :kissing:

[amaranthe]

Sorry to hear you are going thru this, Kara. I have dealt with constipation in the past and it was the worst pain imaginable! This is going to sound gross, but when I was like that this is what I did. I mixed the Lidocaine jelly and hemmoroid cream. Then, I put on gloves and coated my anus with that mixture and the rectal canal. Then, I let it sit for a few minutes to help make things more comfortable. Then, I use a mineral oil enema or some glycerin suppositories, to help soften and lubricate the stool. Then, I try to very gently manually remove any hard stools that I can feel. After that, if I still cant go, I use another mineral oil enema and recoat my rectum (this time just the end) with the Lidocaine/hemmoroid cream mixture. While I am waiting for this to work, I try to drink as much water as possible too. Usually, after this, I am able to get relief. Please okay anything you try with your Dr. I am just telling you what worked for me personally, but we are all different, so make sure you okay things with your Dr. before trying anything.

For me, following a bowel regime is important. Part of the maintance is making sure I drink TONS of water and trying to get up and walk around the house some every hour, (even on days I feel horrible). The walking helps get the GI track moving. Also, Miralax helps me for maintance. Also, if I havent had a bowel movement in 2 days, I take Ex-lax or use an enema. If one thing doesnt work, then I do both (per my Gastro's instructions.)

I am sorry your Drs wont r/x this new med for you. But please go to the ER if you need help. I hate going to and would rather cut off the body part than go to the ER, LOL! So BELIEVE ME, I know how bad you hate going! But, if you have tried everything on your own and still havent had one and are in pain, then you really need to go there.

I hope you feel better soon!

[wolfaleena]

hi Kara:
I read your post and I am wondering how you are?
I will pray for you.. you have been through so much.

[jen74]

Hi kara.
I was wondering, when you say your are constipated and enemas do not even help, I am guessing that you are backed up higher up in the bowel( which an enema would do nothing to help). I have quite a few friends who have gastroparesis and constipation is a huge issue for them since the intestines do not move well. I was just curious if they ever tried you on the med reglan which is a intestinal stimulant? I use to take domperidone(this is not FDA approved but my gastroenterologist had me taking it anyways( through a compound pharmacy) since it had less side effects than reglan). My symptoms were severe fullness even after eating just a small amount, bloating, nausea.
Maybe you could ask your doctor about this, if you have not already tried it that is. It is a intestinal stimulant and helps the instestines push the food through. I am sure you have tried everything, but I just thought I would share. I am thinking you need to attack the issue at both ends, to help the upper intestines move faster. I am sorry you are going through this. Are they doctors thinking it is obstructions causing this?
Though you say they do CT scans and that would pick up a obstruction I would think. There is the pseudoobstruction thing as well ( where your bowels will actually act as if there is an obstruction when there really is not one. I sure hope you get some relief. Hugs to you.
Jen

[Jeff]

Kara,may i suggest you send an e-mail to this trial manager:
clintrialparticipation@wyeth.com

This is to get in contact with doctors in your area:

http://www.clinicaltrials.gov/ct2/show/NCT00529087?term=relistor&rank=9